Riik: Malta
keel: inglise
Allikas: Medicines Authority
STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Germany
B01AE07
DABIGATRAN ETEXILATE 150 mg
HARD CAPSULE
DABIGATRAN ETEXILATE 150 mg
POM
ANTITHROMBOTIC AGENTS
Authorised
2024-02-26
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DABIGATRAN ETEXILATE STADA ARZNEIMITTEL AG 150 MG HARD CAPSULES dabigatran etexilate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Dabigatran etexilate STADA Arzneimittel AG is and what it is used for 2. What you need to know before you take Dabigatran etexilate STADA Arzneimittel AG 3. How to take Dabigatran etexilate STADA Arzneimittel AG 4. Possible side effects 5. How to store Dabigatran etexilate STADA Arzneimittel AG 6. Contents of the pack and other information 1. WHAT DABIGATRAN ETEXILATE STADA ARZNEIMITTEL AG IS AND WHAT IT IS USED FOR Dabigatran etexilate STADA Arzneimittel AG contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot formation. Dabigatran etexilate STADA Arzneimittel AG is used in adults to: - prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor. - treat blood clots in the veins of your legs and lungs and to prevent blood clots from re- occurring in the vein of your legs and lungs. Dabigatran etexilate STADA Arzneimittel AG is used in children to: - treat blood clots and to prevent blood clots from reoccurring. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DABIGATRAN ETEXILATE STADA ARZNEIMITTEL AG DO NOT TAKE DABIGATRAN ETEXILATE STADA ARZNEIMITTEL AG Lugege kogu dokumenti
1 1. NAME OF THE MEDICINAL PRODUCT Dabigatran etexilate STADA Arzneimittel AG 150 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 172.95 mg of dabigatran etexilate (as mesilate) equivalent to 150 mg of dabigatran etexilate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Off white to pale yellow coloured pellets filled in blue cap and white to off white body hard capsules size 0 (approx. 21.7 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age ≥ 75 years; heart failure (NYHA Class ≥ II); diabetes mellitus; hypertension. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Treatment of venous thromboembolic events (VTE) and prevention of recurrent VTE in paediatric patients from birth to less than 18 years of age. For age appropriate dose forms, see section 4.2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dabigatran etexilate STADA Arzneimittel AG capsules can be used in adults and paediatric patients aged 8 years or older who are able to swallow the capsules whole. There are other age appropriate dose forms for the treatment of children below 8 years. When changing between the formulations, the prescribed dose may need to be altered. The dose stated in the relevant dosing table of a formulation should be prescribed based on the weight and age of the child. _PREVENTION OF STROKE AND SYSTEMIC EMBOLISM IN ADULT PATIENTS WITH NVAF WITH ONE OR MORE RISK _ _FACTORS (SPAF) _ _TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE), AND PREVENTION OF _ _RECURRENT DVT, AND PE IN ADULTS (DVT/PE) _ _ _ The recommended doses of dabigatran etexilate in the indications SPAF, DVT and PE are shown in table 1. 2 Table 1: Dose recommendations for SPAF, DVT and PE DO Lugege kogu dokumenti